Regulatory Submissions:
Accurate FDA Consultants provides our clients guidance through the entire regulatory submission process, we can assist you no matter what stage you are in.
Our consultants have extensive industry experience in preparing submissions and have an excellent track record for interfacing with the appropriate regulatory authorities and helping firms achieve their regulatory objectives.
We provide the following Regulatory Services:
Medical Devices and IVD Submissions
- Pre-Submissions (Pre-subs/Q-Subs)
- Pre-Market Notifications (510(k)
- Investigational Device Exemption (IDE)
- 513(g) Request for Classification
- Pre-Market Approval (PMA)
- PMA Supplements (30-day/135-day, 180-day, Real Time, Special, Panel Track)
- PMA Annual Reports
Pharmaceutical and Generics Submissions
- Investigational New Drug (IND)
- Abbreviated New Drug Application (ANDA)
- Post approval Submissions
Combination Products Submissions
- Request for Designation (RFD)
Experienced U.S. Agent – Registration and Listing
Accurate FDA Consultants continues to serve a multitude of satisfied foreign medical device and pharmaceutical clients around the world, as their US Agent. We can register your establishment and list your products. We will serve as your conduit between your firm and the FDA, to schedule inspections and intercept custom disputes and issues. Click here for more details.
